Ethicon, Inc., a member of the Johnson & Johnson's Family of Companies, is recruiting for a Staff Supplier Quality Engineer to be located at any of the Ethicon site including Cincinnati- OH, Cornelia- GA, Athens-GA, San Lorenzo- Puerto Rico, Guaynabo- Puerto Rico, Norderstedt- Germany, Neuchatel- Switzerland, Sao Jose Dos Campos- Brazil, San Angelo- TX, Juarez- Mexico, with preferred location to be Somerville- NJ.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation.
The Staff Supplier Quality Engineer will be responsible for external suppliers of raw materials and finished goods for the Ethicon franchise. He/she leads the deployment of the Supplier Quality Management (SQM) strategy and associated standards, policies, procedures, programs, systems, processes, and initiatives for direct material suppliers of the Ethicon Supply Chain.
This individual will actively leverage talents and lead teams, collaborates with Strategic Sourcing, R&D, Engineering, Quality, Operations, business partners/stakeholders, and external suppliers to implement solutions and improve suppliers’ Quality, service and performance. In this role, the individual leads the development and execution of plans, strategies, systems, processes, and procedures to ensure robust supplier/purchasing controls with regard to the determination, selection, qualification, monitoring, and disengagement of suppliers. He/she proactively identifies, develops, and leads the investigation and resolution of supplier-related challenges, and implements appropriate Quality Engineering methodologies, statistical techniques, process capability analyses/improvements, DOE/process optimization, and other technical or Process Excellence tools in support of innovations, supplier-related changes, risk management, product/process transfers, material upgrades, and continuous process enhancements to improve supplier reliability, minimize risks, and ensure sustainable sources of material supply capable of meeting or exceeding Quality, Compliance, and Business requirements.
The individual will:
• Provide timely business support for Ethicon Supplier Quality Management (SQM) function globally
• Lead, develop, and implement supplier/purchasing controls and associated activities including ASL management
• Participate in and/or lead the identification, selection, qualification, monitoring, and disengagement of suppliers for SQM
• Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems
• Partner with Procurement/Source, R&D, Engineering, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions
• Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes
• Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and closure communication including ASL updates and GMP Qualifications
• Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision
• Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects
• Apply appropriate Quality Engineering and Process Excellence tools (e.g. CTx, PM/VSM, Kaizen, DMAIC, FMEA/FTA, RCA, MSA, SPC, Cpk/Ppk, Hypothesis Testing, ANOVA/DOE/EVOP, etc.) to support innovations and continuous improvements
• Identify business opportunities for and lead the preparation/management of Supplier Quality Agreements (SQA)
• Execute Quality Risk Management process for required supplier-related matters with appropriate subject-matter experts
• Ensure alignment of SQM Quality Systems with current regulatory requirements, industry trends, J&J standards, policies, procedures, and work instructions
• Lead and provide SQM support for appropriate site Quality and Compliance audits related to supplier/purchasing controls Qualifications
• A minimum of a Bachelor's degree in required. A technical/scientific discipline is required; a degree in Engineering is preferred
• A minimum of 5 years of Quality/ Engineering work experience is required
• Working experience in a highly regulated environment (medical device, pharmaceutical, etc.) is preferred
• Practical experience with GMP documentation and writing skills in the FDA regulated environment is required
• Broad experience with GxP Quality Systems, including but not limited to investigations, qualification/validation, CAPA, Supplier/Purchasing Controls, SQA, material/production/process controls, and supplier certification is strongly preferred
• Working experience of Medical Device-Metal/Plastic/Packaging and Medical Device Validation is a great advantage
• Demonstrated practical knowledge and skills in and application of SQM, QSRs, and ISO13485 are highly desirable
• Professional Certification, training, or working knowledge/skills in Project Management/FPX is strongly preferred
• Professional Certifications: ASQ CQE, CSQP, CMQ/OE, CSSGB, CSSBB, and/or CQA strongly preferred
• Process Excellence Certification (J&J Six-Sigma/Lean Green Belt/Black Belt) is preferred
• Working knowledge of Quality Risk Management tools (e.g. ISO 14971, FMEA/FMECA/FTA/HACCP, etc.) preferred
• Familiarity with component/process/equipment qualifications and validations is desirable
• Strong leadership, organization, interpersonal, and communication skills are an asset
• This position may require up to 35 % travel international and domestic depending on location of the role and can be based in any Ethicon site including Cincinnati- OH, Cornelia- GA, Athens-GA, San Lorenzo- Puerto Rico, Guaynabo- Puerto Rico, Norderstedt- Germany, Neuchatel- Switzerland, Sao Jose Dos Campos- Brazil, San Angelo- TX, Juarez- Mexico, with preferred location to be Somerville- NJ.
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J2W: LI NAPrimary Location
United States-New Jersey-SomervilleOther Locations
North America-United States-Texas-San Angelo, North America-United States-Puerto Rico-San Lorenzo, Latin America-Brazil-São Paulo-São José dos Campos, Europe/Middle East/Africa-Germany-Schleswig Holstein-Norderstedt, North America-United States-Georgia-Athens, Europe/Middle East/Africa-Switzerland-Neuchâtel-Neuchâtel, North America-United States-Puerto Rico-Guaynabo, Latin America-Mexico-Chihuahua-Juarez, North America-United States-Georgia-Cornelia, North America-United States-Ohio-CincinnatiOrganization
Ethicon Inc. (6045)Job Function
Quality (Eng)Requisition ID
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